Abdominal Cancer, Cancer, Malignant Tumors, Cancer Pain, Cancer-related Pain, Celiac Ganglia, Pain Management, Sympathetic Ganglia, Visceral Pain
Conditions
Keywords
cancer pain, visceral pain, abdominal cancer, cancer, abdominal pain, cancer-related pain, pain management, neurolytic block, splanchnic nerve block, celiac plexus block, sympathetic neurolysis
Brief summary
The neurolytic blocks of sympathetic chains are commonly used for the treatment of cancer-related pain. This study aims to compare celiac plexus neurolysis and splanchnic nerve neurolysis for the treatment of abdominal visceral pain and its influence on the quality of life of patients with cancer.
Detailed description
Double-blind randomized clinical trial. The objective of the study is to compare the analgesic efficacy of splanchnic nerve neurolysis with alcohol to celiac plexus block with alcohol, with pain relief as the primary outcome. It also aims to quantify the adverse effects of the techniques as secondary outcomes. The sample size calculation will be based on comparing the mean pain scores on the Numerical Rating Scale of patients in the Control Group and the Intervention Group, evaluated after completing the second month of treatment. A two-tailed t-test will be sufficient and will require an adequate sample size. Therefore, for the chosen sample design with a significance level of α=5%, a power of 1-β=80%, assuming M1=5.0 and M2=3.5 and a standard deviation of 2.0, the sample size required is n=58. the sample size required is n=58. Considering a 10% dropout rate, the final sample size will be increased to 64 participants. Convenience sampling (a non-probabilistic sampling method) will be used. Participants will be randomly allocated to the groups using a list generated by a program obtained at https://www.randomizer.org. The proportion between the participants in the groups will be 1:1, with 32 patients allocated to the Intervention arm and 32 to the Control arm. The allocation of the total 64 participants will be determined by randomly assigned sequential letters (A or B) generated by the computer (website https://www.randomizer.org), randomly assigning numbers from 0 to 64 to each group: Control Group (Celiac Block) and Intervention Group (Splanchnic Nerve Block). The Control Group will receive celiac plexus neurolysis with absolute alcohol, and the Intervention Group will receive splanchnic nerve neurolysis with alcohol. The statistical analysis will be performed in program R version 3.5.1. The results obtained will be presented as mean + standard deviation for continuous data or absolute frequency for described data. For quantitative variables, the Student's t-test will be used for normally distributed data, or the Mann-Whitney test for non-normally distributed data. For qualitative variables, the chi-square test will be used or Fisher's exact test. Significant difference is defined as p \< 0.05. Data will be collected and managed using REDCap data capture tools.
Interventions
PROCEDURESplanchnic nerve neurolysis - 5 ml of absolute alcohol (100%)
Splanchnic neurolysis will be performed with 5 ml of absolute alcohol on each side at the level of the eleventh thoracic vertebra.
PROCEDURECeliac Plexus Neurolysis - 5 ml of absolute alcohol (100%)
Celiac plexus neurolysis will be performed with 5 ml of absolute alcohol on each side at the level of the first lumbar vertebra.
Sponsors
Instituto do Cancer do Estado de São Paulo
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Patients aged 18 years or older Presence of localized visceral pain in the upper abdomen originating from cancer of the stomach, duodenum, distal esophagus, ascending or transverse colon, liver, biliary tract, or pancreas Ineffectiveness of analgesic treatment with third-step opioids according to the WHO analgesic ladder, including: Opioids (≥ 60 mg/day of morphine equivalents) Antidepressants (tricyclic or dual-action), at any dosage Gabapentinoids, at any dosage Presence of side effects from analgesics that are difficult to manage with medication
Exclusion criteria
Presence of ascites Presence of deep vein thrombosis Presence of hepatic failure: Child-Pugh class B or C Presence of renal failure: estimated glomerular filtration rate (eGFR) \< 60 ml/min/1.73 m² Use of any anticoagulant medication Clinical coagulation disorder, defined as: INR \> 1.5 Prothrombin activity \< 70% or prothrombin time \> 13.5 seconds aPTT \> 40 seconds Cardiovascular failure: NYHA class III
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| PAIN SCORE | 1st Day Post-procedure; 15th Day Post-procedure; 30th Day Post-procedure; 2nd Month Post-procedure | Pain will be assessed using the Numerical Rating Scale (NRS), a scale from 0 to 10 where: 0 indicates no pain and 10 indicates the worst possible pain. Scores are typically categorized as: Mild pain: 0-3 Moderate pain: 4-6 Severe pain: 7-10 Additionally, the Descriptive Verbal Scale will be used, with the following categories: No pain Mild pain Moderate pain Severe pain. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Quality of life assessment. | 1st Day Post-procedure; 15th Day Post-procedure; 30th Day Post-procedure; 2nd Month Post-procedure | Quality of life will be assessed using the Brief Pain Inventory - Short Form (SF-36) questionnaire, which evaluates both pain intensity and its impact on daily functioning. The questionnaire covers two main areas: Pain Severity - Patients rate their pain at its: Worst Least Average Current (right now) (using a 0-10 numeric scale, where 0 = no pain and 10 = pain as bad as you can imagine). Pain Interference - Assesses how much pain interferes with: General activity Mood Walking ability Normal work Relationships with others Sleep Enjoyment of life (also rated on a 0-10 scale, where 0 = does not interfere and 10 = completely interferes). Additionally, the questionnaire includes: A pain location diagram Information about current pain medications and their effectiveness Description of pain relief methods. |
| Adverse Events | 1st Day Post-procedure; 15th Day Post-procedure; 30th Day Post-procedure; 2nd Month Post-procedure | Adverse events inherent to the studied procedures will be assessed and recorded. These include: Abdominal pain; Diarrhea; Hypotension (low blood pressure); Back pain; Nausea and vomiting; Fever; Bloating or abdominal distention; Delayed gastric emptying; Injury to surrounding structures (e.g., blood vessels or organs); Nerve damage; Impaired digestive function; Local infection at the puncture site; Loss of autonomic function; Pneumothorax. |
Countries
Brazil
Contacts
Primary ContactAngela M Sousa, MD. PhD.
Backup ContactKarenthan A Rodrigues, MD.
Outcome results
None listed